Endoscopy has been used for a variety of diagnostic and surgical procedures in the medical field, as well as other non-medical fields, for many years. In a typical medical endoscopy procedure, an endoscope, which commonly includes a body having flexible and/or rigid structural elements along with an imaging element such as a camera and/or lens assembly and lighting, is inserted into a body orifice such as the nose, throat, or rectum and is then positioned to view conditions inside the body. Some endoscopes are configured in an ingestible pill form (denoted herein as “pill-type” endoscopes to distinguish them from traditional endoscopes) that is swallowed and travels through the body while collecting diagnostic information.
In order to prevent introduction of germs or other foreign matter into the body, endoscopes are frequently reprocessed using sterilization equipment, disinfected in a germicidal solution or enclosed by a sheath, which is typically made of a pliable material which conforms to the shape of the endoscope body and isolates any contamination from the endoscope. Currently used endoscope sheaths are costly, one time use disposable components that primarily act as passive covers for the endoscope, without providing any additional diagnostic functionality. Moreover, in many cases, endoscope sheaths may act to limit or inhibit endoscope functionality by imposing a barrier between the endoscope and the patient's body part being examined. For example, components incorporated into the endoscope, such as imaging elements, may have reduced optical performance due to the sheath and condensation that may occur between the sheath and the endoscope lens. Sensor integral to the endoscope may also be rendered non-functional when covered by the sheath.
Problems with endoscope and sheath sterilization have received attention from organizations such as the FDA and CDC, which have promulgated publications including “Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose and Throat Endoscope Sheaths Used as Protective Barriers,” at //www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073746.htm, “FDA and CDC PUBLIC HEALTH ADVISORY, Infections from Endoscopes Inadequately Reprocessed by an Automated Endoscope Reprocessing System,” at http://www.olympusamerica.com/msg_section/files/FDAadvisory.pdf, “FDA Public Health Notification: Updated Information on Customer Ultrasonics, Inc., Endoscope Washer/Disinfectant.” at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/UCM062075. Concerns have led to investigations of the value of sheaths as barrier functions for endoscopy, see, e.g., EVALUATION OF PROTOCOLS FOR TESTING ENDOSCOPE SHEATHS AS VIRAL BARRIERS, Baker, et al., FDA Science Forum, 1997, which is incorporated by reference herein.
While sheaths have been used for some time in endoscopy, they have not been used to provide other sensory inputs or actuator functions to improve diagnosis and treatment. Accordingly, there is a need in the art for improved endoscope sheaths, as well as associated medical diagnostic, analytic and treatment techniques.